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• W2140486586 abstract "In this issue of Pediatric Critical Care Medicine, Warren and colleagues (1) provide a detailed review of literature related to the use of recombinant factor VII (rFVIIa) in pediatric cardiac surgery. From the time initial Food and Drug Administration approval was granted for its use as an agent to treat bleeding episodes in patients with hemophilia A or B and inhibitors to factor VIII or factor IX in 1999, “off-label” use of rFVIIa has become increasingly common, with several randomized controlled trials being published during the previous year (2–4). However, as noted by Dr. Warren and colleagues, the number of published reports describing the use of rFVIIa in pediatric cardiac surgical patients is limited. Although not absolutely applicable to pediatric patients, insights garnered from the adult literature often provide an important framework from which pediatric therapeutic guidelines may be formulated. During the first 6 yrs after rFVIIa received Food and Drug Administration licensing, 431 adverse events were reported to the Food and Drug Administration’s Adverse Event Reporting System (5). Approximately 40% of these events were thromboembolic in nature, including cerebrovascular accidents, acute myocardial infarction, arterial thrombosis, pulmonary embolism, venous thrombosis, and clotted devices. Thromboembolic complications were determined to be the probable cause of 72% of the deaths reported. Notably, off-label use of rFVIIa accounted for 90% of the adverse events reported. During the first 10 mos postexpansion of Food and Drug Administration-approved indications in 2005, 61 additional thromboembolic adverse events and seven thrombosis-related deaths were reported. Off-label use accounted for 88% of the additional reported events. A recent meta-analysis of 22 randomized controlled trials involving predominantly adult nonhemophiliac patients demonstrated a tendency toward reduced transfusion requirement (odds ratio = 0.54), reduced mortality (odds ratio = 0.88), and increased arterial thromboembolic complications (odds ratio = 1.50) in patients receiving rFVIIa compared with placebo (6). Another recently published review of adult cardiac surgery patients who received rFVIIa similarly describes reduced transfusion requirements post rFVIIa administration (7). However, 4% of the patients in the study also developed thromboembolic complications that were attributable to rFVIIa. Importantly, rFVIIa-associated thrombotic complications may be associated with significant morbidity and mortality. In a review of 46 pediatric patients with postcardiotomy bleeding, Agarwal and colleagues reported that 21% patients who received rFVIIa required surgical reexploration of the mediastinum for evacuation of clots (8). Overall, 25% of the patients in the series developed thromboses after rFVIIa therapy. Administration of rFVIIa to patients who require extracorporeal life support seems to be a particularly important risk factor for thrombotic complications. There have been several recent reports of adult (9) and pediatric (8, 10, 11) patients experiencing life-threatening or fatal intracardiac thrombosis after receiving rFVIIa at the time they were on extracorporeal life support. As described in the paper by Dr. Warren et al, approximately 20% of extracorporeal membrane oxygenation patients who require rFVIIa develop symptomatic thrombotic complications (1). Although the authors suggested that the rate of venous thrombosis is similar to that observed in rFVIIa-naive extracorporeal membrane oxygenation patients who undergo screening color Doppler sonography (12), careful review of the cited reference reveals that venous thromboses occurred in only 10% of patients during extracorporeal membrane oxygenation support. Furthermore, it is important to make a distinction between significant thrombotic complications that impact clinical outcome and thromboses that are detected by sonographic screening (12). Results of a 2007 Cochrane review of the use of rFVIIa for the prevention and treatment of bleeding in patients without hemophilia indicated that there is a trend in favor of the use of rFVIIa for reducing mortality (risk ratio = 0.82) (13). However, a trend was also noted against the use rFVIIa with respect to thromboembolic adverse events (risk ratio = 1.50). The authors concluded that the use of rFVIIa outside of its current licensed indications should be very limited and its wider use should await the results of ongoing and possibly newly commissioned, randomized controlled trials. In the interim, rFVIIa use should be restricted to clinical trials. The results of a randomized, prospective clinical trial completed in 2006, which examined the use of rFVIIa in bleeding extracorporeal membrane oxygenation patients post cardiac surgery, have yet to be published (14). Without question, rFVIIa is an important therapeutic agent that has a powerful effect on postoperative hemorrhage in cardiac surgery patients. However, careful consideration must be given to potential thrombotic complications associated with its use in pediatric patients, especially those who require extracorporeal life support. As with other therapeutic agents, appropriate patient selection is critical. In general, the literature does not support the use of rFVIIa as a prophylactic or first-line therapeutic option for postoperative hemorrhage. The importance of early correction of “surgical” bleeding, accurate determination of coagulation factor deficiencies, and careful proactive administration of blood products during the intraoperative and perioperative periods cannot be overstated. In patients with truly refractory, life-threatening postoperative hemorrhage, judicious use of rFVIIa may be justified. D. Michael McMullan, MD Seattle Children’s Hospital Seattle, WA" @default.
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• W2140486586 date "2009-09-01" @default.
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• W2140486586 title "Relative risks of recombinant factor VII*" @default.
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• W2140486586 doi "https://doi.org/10.1097/pcc.0b013e3181ae49e1" @default.
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